Prednisone has been related to the side effect of Abdominal pain upper. If you are taking Prednisone and have experienced Abdominal pain upper this information may be of use to you.
IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.
PredniSONE TABLETS, USP Rx Only
PREDNISONE
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prednisone tablet Cadista Pharmaceuticals Inc.
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PredniSONE TABLETS, USP Rx Only
DESCRIPTION
Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which
are readily absorbed from the gastrointestinal tract. The molecular formula for prednisone is C21H26O5. Chemically, it is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione and has the following structural formula:
Molecular weight: 358.44
Prednisone is a white to practically white, odorless, crystalline powder. It melts at about 230°C with some decomposition.
Prednisone is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol.
Each tablet, for oral administration, contains 1 mg of prednisone.
Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as
replacement therapy in adrenocortical deficiency states. Their synthetic analogs, such as prednisone, are primarily used for
their potent anti-inflammatory effects in disorders of many organ systems.
Glucocorticoids, cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse
stimuli.
INDICATIONS AND USAGE
Prednisone tablets are indicated in the following conditions:
1. Endocrine Disorders:
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may
be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular
importance).
Congenital adrenal hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
2. Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Psoriatic arthritis
Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
Ankylosing spondylitis
Acute and subacute bursitis
Acute nonspecific tenosynovitis
Acute gouty arthritis
Post-traumatic osteoarthritis
Synovitis of osteoarthritis
Epicondylitis.
3. Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Systemic dermatomyositis (polymyositis)
Acute rheumatic carditis
4. Dermatologic Diseases
Pemphigus
Bullous dermatitis herpetiformis
Severe erythema multiforme (Stevens-Johnson syndrome)
Exfoliative dermatitis
Mycosis fungoides
Severe psoriasis
Severe seborrheic dermatitis
5. Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitis
Bronchial asthma
Contact dermatitis
Atopic dermatitis
Serum sickness
Drug hypersensitivity reactions
6. Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic corneal marginal ulcers
Herpes zoster ophthalmicus
Anterior segment inflammation
Diffuse posterior uveitis and choroiditis
Sympathetic ophthalmia
Allergic conjunctivitis
Keratitis
Chorioretinitis
Optic neuritis
Iritis and iridocyclitis
7. Respiratory Diseases
Symptomatic sarcoidosis
Loeffler's syndrome not manageable by other means
Berylliosis
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
Aspiration pneumonitis
8. Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults
Secondary thrombocytopenia in adults
Acquired (autoimmune) hemolytic anemia
Erythroblastopenia (RBC anemia)
Congenital (erythroid) hypoplastic anemia
9. Neoplastic Diseases
For palliative management of:
Leukemias and lymphomas in adults
Acute leukemia of childhood
10. Edematous States
To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that
due to lupus erythematosus
11. Gastrointestinal Diseases
To tide the patient over a critical period of the disease in:
Ulcerative colitis
Regional enteritis
12. Nervous System
Acute exacerbations of multiple sclerosis
13. Miscellaneous
Tuberculous meningitis with subarachnoid block or, impending block when used concurrently with appropriate antituberculous
chemotherapy.
Trichinosis with neurologic or myocardial involvement.
CONTRAINDICATIONS
Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components.
WARNINGS
In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before,
during, and after the stressful situation is indicated.
Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased
resistance and inability to localize infection when corticosteroids are used.
Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves,
and may enhance the establishment of secondary ocular infections due to fungi or viruses.
Usage in Pregnancy
Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing
mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential
hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids
during pregnancy, should be carefully observed for signs of hypoadrenalism.
Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and
increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in
large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium
excretion.
While on corticosteroid therapy patients should not be vaccinated against smallpox. Other immunization procedures should
not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological
complications and a lack of antibody response.
The use of prednisone tablets in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis
in which the corticosteroid is used for the management of the disease in conjunction with an appropriate anti-tuberculous
regimen.
If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary
as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox
and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids.
In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose,
route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known.
The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed
to chickenpox, prophylaxis with varicella-zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis
with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and
IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.
PRECAUTIONS
General
Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative
insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during
that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid
should be administered concurrently.
There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.
Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.
The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in
dosage is possible, the reduction should be gradual.
Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.
Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes,
and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may
be aggravated by corticosteroids.
Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation,
abscess or other pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency;
hypertension; osteoporosis; and myasthenia gravis.
Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations
of multiple sclerosis, they do not show that corticosteroids affect the ultimate outcome or natural history of the disease.
The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See
DOSAGE AND ADMINISTRATION)
Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment,
a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily
or intermittent therapy should be used.
Convulsions have been reported with concurrent use of methylprednisolone and cyclosporine. Since concurrent use of these
agents results in a mutual inhibition of metabolism, it is possible that adverse events associated with the individual use
of either drug may be more apt to occur.
Information for the Patient
Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles.
Patients should also be advised that if they are exposed, medical advice should be sought without delay.
ADVERSE REACTIONS
Fluid and Electrolyte Disturbances:
Sodium retention.
Fluid retention.
Congestive heart failure in susceptible patients.
Potassium loss.
Hypokalemic alkalosis.
Hypertension.
Musculoskeletal:
Muscle weakness.
Steroid myopathy.
Loss of muscle mass.
Osteoporosis.
Vertebral compression fractures.
Aseptic necrosis of femoral and humeral heads.
Pathologic fracture of long bones.
Gastrointestinal:
Peptic ulcer with possible perforation and hemorrhage.
Pancreatitis.
Abdominal distention.
Ulcerative esophagitis.
Dermatologic:
Impaired wound healing.
Thin fragile skin.
Petechiae and ecchymoses.
Facial erythema.
Increased sweating.
May suppress reactions to skin tests.
Metabolic:
Negative nitrogen balance due to protein catabolism.
Neurological:
Convulsions
Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment.
Vertigo.
Headache.
Endocrine:
Menstrual irregularities.
Development of Cushingoid state.
Suppression of growth in children.
Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness.
Decreased carbohydrate tolerance.
Manifestations of latent diabetes mellitus.
Increased requirements for insulin or oral hypoglycemic agents in diabetics.
Ophthalmic:
Posterior subcapsular cataracts.
Increased intraocular pressure.
Glaucoma.
Exophthalmos.
Additional Reactions:
Urticaria and other allergic, anaphylactic or hypersensitivity reactions.
DOSAGE AND ADMINISTRATION
The initial dosage of prednisone may vary from 5 mg to 60 mg per day depending on the specific disease entity being treated.
In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required.
The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period
of time there is a lack of satisfactory clinical response, prednisone should be discontinued and the patient transferred to
other appropriate therapy.
IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER
TREATMENT AND THE RESPONSE OF THE PATIENT.
After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage
in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response
is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations
which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the
disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations
not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage
of prednisone for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be
stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis
In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by
80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)
ADT ® (Alternate Day Therapy)
ADT is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning.
The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial
effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid
state, corticoid withdrawal symptoms, and growth suppression in children.
The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect
of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid
every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the
off-steroid day.
A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus
a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise
in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum
levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical
activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol
dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with
lowest levels occurring about midnight.
The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized
by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension,
latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted
during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear,
then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant
role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short
periods of time may be instrumental in protecting against undesirable pharmacologic effects.
During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of
cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and
duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown
that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to
a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may
be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of
certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone,
hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for
11/4 to 11/2 days following a single dose) and thus are recommended for alternate day therapy.
The following should be kept in mind when considering alternate day therapy:
1) Basic principles and indications for corticosteroid therapy should apply. The benefits of ADT should not encourage the
indiscriminate use of steroids.
2) ADT is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated.
3) In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with
ADT. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process.
The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten
days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as
brief as possible particularly when subsequent use of alternate day therapy is intended.
Once control has been established, two courses are available: (a) change to ADT and then gradually reduce the amount of corticoid
given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective
level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable.
4) Because of the advantages of ADT, it may be desirable to try patients on this form of therapy who have been on daily corticoids
for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA
axis, establishing them on ADT may be difficult and not always successful. However, it is recommended that regular attempts
be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this
every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled,
an attempt should be made to reduce this dose to a minimum.
5) As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not
recommended for alternate day therapy (e.g., dexamethasone and betamethasone).
6) The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous
corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am).
7) In using ADT it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient.
Complete control of symptoms will not be possible in all patients. An explanation of the benefits of ADT will help the patient
to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other
symptomatic therapy may be added or increased at this time if needed.
8) In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided
corticoid dose for control. Once control is again established alternate day therapy may be re-instituted.
9) Although many of the undesirable features of corticosteroid therapy can be minimized by ADT, as in any therapeutic situation,
the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.
HOW SUPPLIED
Prednisone Tablets, USP are available in the following strengths and package sizes:
1 mg (white, round, scored imprinted with TL 171)
Bottles of 100 NDC 59746-171-06
Bottles of 1000 NDC 59746-171-10
Store at 20o to 25oC (68o to 77oF) [See USP Controlled Room Temperature].
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